FDA Clears AccurKardia's AccurECG 2.0 Software for Automated Ambulatory ECG Analysis

New York-based AccurKardia said on January 8 that the U.S. Food and Drug Administration has cleared version 2.0 of its AccurECG Analysis System, software that automatically interprets recorded ambulatory electrocardiogram (ECG) data, and that it has begun selling the product. The company's announcement was distributed by Business Wire and read via MedTech Innovator, which reposted it.

The FDA's 510(k) database lists the AccurECG Analysis System (v2.0) as K252361, a traditional 510(k) received on July 29, 2025 and found substantially equivalent on December 22, 2025. It is classified under the electrocardiograph regulation, 21 CFR 870.2340, with product code DPS. The company said this is the second 510(k) clearance for the AccurECG platform.

What was cleared

According to the clearance letter and 510(k) summary, the software is intended for qualified health care professionals assessing a patient's recorded ambulatory ECG data. It provides single-lead, beat-by-beat analysis, detects ventricular and supraventricular ectopic beats, measures heart rate and analyzes rhythm, and produces a standard report for review and printing. It is intended for recordings from adults aged 22 and older made with wet silver/silver chloride electrodes.

The labeling sets limits. The system is not for use in life-supporting systems or in ECG monitor and alarm devices, is not intended for cardiac telemetry monitors, and its automated interpretations are not intended to be the sole means of diagnosis. The summary describes the report as an adjunct to the physician's own reading and other clinical information, and says the software is device independent and prescription only.

The predicate is AccurKardia's own earlier AccurECG Analysis System, version 1.3.0, cleared under K223013. The summary says the new version changes the operating system and programming language, while the intended use, indications and principles of operation remain identical. Comparative testing found statistical equivalence with the predicate, with every measured parameter's 95% confidence interval inside the specified margin, and the algorithm was tested to the AAMI/ANSI EC 57 and IEC 60601-2-47 standards, the document says.

Company claims

AccurKardia says the system interprets 13 rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia, and can take data from patches, Holter monitors and other ECG devices without custom integrations, Medical Economics reported. The company also said the platform achieves 99% accuracy across FDA-cleared arrhythmia classifications; that figure is the company's and is not stated in the FDA summary.

The software is aimed at cardiac monitoring companies, device makers, hospitals and independent diagnostic testing facilities, according to the report.

“This clearance positions us to accelerate go-to-market efforts in the first half of 2026,” Juan C. Jiménez, co-founder and chief executive, said, as quoted by Medical Economics. Chief medical officer Nav Razvi said, “As remote care continues to expand, software that improves efficiency while maintaining clinical standards can help extend access, especially in areas with limited specialist coverage.”